We can generally classify most medical devices and in vitro diagnostics (IVDs) very easily based on experience. However, there are situations where a new medical device or IVD may be difficult to classify. For example, devices that have been classified as 510(k) exempt by the FDA but possess new technology or are marketed for a different intended use than the classified device should have their classification and route to compliance verified by the FDA.
In these cases, we can submit a 513(g) document to the FDA on your behalf seeking a classification confirmation, or in unusual circumstances, a classification determination. We can prepare and submit a 513(g) document to the FDA outlining the characteristics of the device and our rationale for why it should fall into a specific class. The FDA will then render a decision on how the device should be classified.